The following data is part of a premarket notification filed by Advance Medical Device, Inc. with the FDA for Floscope Microdop.
| Device ID | K910441 |
| 510k Number | K910441 |
| Device Name: | FLOSCOPE MICRODOP |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | ADVANCE MEDICAL DEVICE, INC. P.O. BOX 409 Berlin, NJ 08009 |
| Contact | David Lerner |
| Correspondent | David Lerner ADVANCE MEDICAL DEVICE, INC. P.O. BOX 409 Berlin, NJ 08009 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-31 |
| Decision Date | 1991-03-21 |